Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- bimanual functional performance, "change" is being assessed
研究概览
简要总结
This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.
详细描述
the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
- •Ages between 5 to 10 years.
- •Levels of I-III within the , manual ability classification system, MACS.
- •Levels of I-III within the gross motor function classification system, GMFCS
排除标准
- •Diseases not associated with infantile hemiparesis.
- •Low cognitive level to understand the execution of activities.
- •Surgeries of the upper extremity during the 6 months prior to the intervention.
- •Structured contractures in the affected upper extremity that cause functional impotence.
- •Botulinum toxin two months prior to the intervention and application of it during the treatment.
- •Epilepsy not controlled pharmacologically
结局指标
主要结局
bimanual functional performance, "change" is being assessed
时间窗: 4 assessments will be carried out in the research in 10 weeks
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.
次要结局
- quality of life ,"change" is being assessed(4 assessments will be carried out in the research in 10 weeks)
研究者
Rocío Palomo Carrión
physiotherapist
University of Salamanca